Systems Engineer II (Medtech)

TL;DR

Systems Engineer II (Medtech): Supporting system engineering for new and existing product development with an accent on mobile applications and globalization. Focus on defining system-level requirements, interface specifications, and ensuring end-to-end clinical and non-clinical customer workflows.

Location: Hybrid (Del Mar, CA). Must be based in the US and authorized to work for any employer in the US; no sponsorship provided.

Salary: $81,000 - $110,000

Company

hirify.global creates innovative products and services for people living with diabetes, including the Tandem Mobi and t:slim X2 insulin pumps.

What you will do

• Develop, document, and maintain system and subsystem requirements and designs with a globalization mindset.
• Provide system expertise for troubleshooting on-market products, failure analysis, and triage of system-level issues.
• Define and maintain inter-system interface specifications and contracts, assessing cross-subsystem impacts.
• Contribute to the risk management process and derive necessary risk mitigation requirements.
• Collaborate with V&V teams to review test plans and triage issues uncovered during testing.
• Work with SW and HW teams to flow down requirements and establish traceability to user and business needs.

Requirements

• Bachelor's degree in System, Electrical, Mechanical, Computer Science, or Biomedical Engineering.
• 2+ years of experience as a Systems Engineer in a multidisciplinary project team environment.
• 2+ years of experience working in a regulated industry (Medical Device industry preferred).
• Proficiency in Systems Engineering practices (requirements management, design trade-offs, failure modes analysis).
• Must be authorized to work in the US (no visa sponsorship available).

Nice to have

• Experience with requirements management systems such as JAMA or DNG.
• Master's degree or professional licensing in a related field.
• Familiarity with ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30, HIPAA, or GDPR.

Culture & Benefits

• Comprehensive healthcare benefits (medical, dental, vision) available from day one.
• Health Savings Accounts (HSA) and Flexible Saving Accounts (FSA).
• 11 paid holidays per year and a minimum of 20 days of paid time off.
• 401k plan with company match and Employee Stock Purchase plan.
• Hybrid work environment with 2-3 days per week in the Del Mar office.